Pharmacoepidemiology of pancreatin use in non-cystic fibrosis patients and comparison of all-cause mortality with that of their matched controls

Date of Approval
Application Number
16_124
Technical Summary

The proposed research will study the pharmacoepidemiology and long-term outcomes associated with Creon pancreatin use in subgroups of patients with pancreatic exocrine insufficiency (PEI) due to aetiologies other than cystic fibrosis and diabetes. Within these subgroups we aim to compare the outcomes of Creon pancreatin-treated cases with non-pancreatin-treated matched controls.

The first part of the proposed research will be descriptive in nature. We aim to describe the therapeutic indications associated with Creon pancreatin therapy; preceding and concomitant treatments; clinical events &/or tests, and treatment pathways which are related/associated to/with Creon pancreatin prescription. The annual prevalence and incidence of PEI within the study observation period will be determined.

Following this we aim to compare the risk of all-cause mortality (ACM) following first-line Creon pancreatin monotherapy with that of matched non-pancreatin-treated PEI or matched diabetic controls respectively. Baseline characteristics will be evaluated to help determine the generalisability of the study population to other populations. Non-parametric univariate analysis of time to ACM will be performed using the Kaplan-Meier (KM) method. Dependent on the data, time to ACM will be modelled using either semi-parametric or parametric multivariate survival models.

Health Outcomes to be Measured

The risk of all-cause mortality (ACM) following first-line Creon pancreatin monotherapy with that of matched non-pancreatin-treated PEI or matched diabetic controls respectively

Collaborators

Chris D Poole - Chief Investigator - Digital Health Labs Limited
Andres Diaz Ramirez - Collaborator - Mylan Inc (closed)
Bridgitte Kalsch - Collaborator - Mylan Inc (closed)
Christian Bannister - Collaborator - Digital Health Labs Limited
Hans-Friedrich Koch - Collaborator - Mylan Inc (closed)
Harald Schrem - Collaborator - Hannover Medical School
Johannes-Matthias Lohr - Collaborator - Karolinska Institute Sweden
Keith J Roberts - Collaborator - University Hospital Bristol
Michael Kirby - Collaborator - The Prostate Centre
Nils Ewald - Collaborator - Justus-Liebig University Giessen

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation